Generics Industry News Search
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February 2008 News Archive |
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Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Granisetron Hydrochloride Tablets, 1 mg (base).
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Teva Pharmaceutical Industries Ltd. announced today that the Company has not relaunched and does not intend to ship additional units of generic Protonix(R) (Pantoprazole Sodium) ...
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Teva on Friday announced, "The company has not relaunched and does not intend to ship additional units of generic Protonix (Pantoprazole Sodium) at this time." ...
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New fees for the Food and Drug Administration to speed review of generic pharmaceuticals and new authority to approve copycat versions of some biotech drugs were proposed in President George W. Bush's budget on Monday....
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Infinity Pharmaceuticals, Inc. and MedImmune today announced that the United States Adopted Names (USAN) Council, in consultation with the World Health Organization (WHO) International Nonproprietary Names Expert Committee, has approved the use of the nonproprietary or generic name "retaspimycin" for the companies' lead heat shock protein 90 (Hsp90) inhibitor...
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Watson Pharmaceuticals, Inc. announced today that the company expects to initiate shipments of alendronate sodium in the 35 and 70 mg once weekly dosage strengths when Fosamax(R) loses market exclusivity, which is anticipated to occur at the close of business on February 6, 2008. Alendronate sodium is the generic version of Merck's Fosamax(R) tablets...
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Cubist Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has received today the re-listing application for its U.S. Patent RE 39,071. Patents are considered listed in the Orange Book upon receipt by FDA, ...
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The FDA has released its reasons on why Cobalt is entitled to the 180 day exclusivity, in spite of a settlement agreement with Innovator. It gives detailed reasoning on this issue.
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At a Senate Finance Committee hearing on Wednesday, Sen. Charles Schumer (D-N.Y.) told HHS Secretary Mike Leavitt that he had spoken with FDA Commissioner Andrew von Eschenbach about crafting a proposal that would give FDA the authority to regulate generic versions of biotechnology drugs and that the two agreed to "sit down and try to do something jointly," CongressDaily reports. Schumer said that he and von Eschenbach agreed to revise Schumer's existing legislation instead of developing a White House bill. Leavitt said he would support the effort.
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Orion Corporation filed a patent infringement lawsuit in the United States to enforce its U.S. Patent No. 5,446,194 ("the '194 patent") against Sun Pharmaceutical Industries Limited ("Sun"), who seeks to market generic versions of Stalevo® tablets (25/100/200 and 37.5/150/200 mg strengths of carbidopa/levodopa/entacapone) in the United States....
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Teva Pharmaceuticals is pleased to announce the introduction and availability of Alendronate Sodium Tablets. This product is AB rated and bioequivalent to Fosamax®* Tablets. Alendronate Sodium Tablets are available in 5 mg, 10 mg, 35 mg, 40 mg, and 70 mg strengths. ...
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Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has launched a generic version of Merck & Co., Inc.'s Fosamax(R) (Alendronate Sodium) Tablets, 70 mg after receiving final approval from the U.S. Food and Drug Administration.
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Ranbaxy Pharmaceuticals Inc. (RPI), a subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. FDA to manufacture and market Cefuroxime Axetil for Oral Suspension USP, 125 mg/5mL and 250 mg/5mL. ...
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PITTSBURGH, Feb. 8 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that Mylan Pharmaceuticals Inc. has obtained an order from an administrative law judge in Florida finding that the inclusion of Levothyroxine Sodium on the state's negative drug formulary is an invalid exercise of legislative authority and that the product should be removed from the negative formulary....
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Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today that the US Food and Drug Administration (FDA) has granted an approval to the Company's Abbreviated New Drug Application (ANDA) for Hydrocodone Bitartrate and Homatropine Methylbromide Syrup, the generic equivalent of Endo Pharmaceuticals' Hycodan(R)....
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Mumbai: Adding fuel to an existing patent controversy involving Swiss drug maker F Hoffman-La Roche Ltd’s anti-infection drug Valcyte in India, the country’s largest drug company by revenue, Ranbaxy Laboratories Ltd, has legally challenged the Chennai patent office’s decision to grant a patent for the drug....
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Federal regulators sued Cephalon Inc. on Wednesday, accusing the company of illegally blocking the sale of low-cost generics to protect its biggest money making drug....
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Pharmaceutical and biotechnology major Wockhardt will be launching Azithromycin tablets in the United States. Wockhardt Limited received approval from the United States Food & Drug Administration (US FDA) for marketing the tablets containing 250mg, 500mg and 600mg Azithromycin, which is used for treating various kinds of infections. Azithromycin is the generic name for the brand Zithromax, sold in the US by Pfizer....
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MUMBAI, India: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for generic Depakote ®, divalproex sodium delayed release tablets.
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On February 14, 2008, FDA granted approval for a generic formulation of Zidovudine Tablets, 300 mg., manufactured by Matrix Laboratories, Inc. of Hyderabad, India. The application was reviewed under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR)...
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Research and Markets (http://www.researchandmarkets.com/reports/c82916) has announced the addition of "European Generic Drug Market Potential" to their offering.
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Akorn, Inc. (NASDAQ:AKRX) today announced the signing of a five-year contract manufacturing and supply agreement with a major U.S. pharmaceutical company. Under the terms of the five-year agreement, Akorn will be responsible for the manufacturing and supply of the ophthalmic drug product. ...
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After nearly a decade of resisting, biotech companies want a law passed this year that lets generic drug companies sell cheaper copies of their medicines.
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Generics accounted for 65 percent of the U.S. market last year, up from 63 percent in 2006, according to data released today at the Generic Pharmaceutical Association's annual industry meeting in Boca Raton, Florida. ...
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Abbott Park, Illinois (NYSE: ABT) — Today, Abbott received U.S. Food and Drug Administration (FDA) approval for SIMCOR®, the first fixed-dose combination of two widely prescribed cholesterol therapies, Niaspan® (Abbott's proprietary niacin extended-release) and simvastatin.
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Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP) and Penwest Pharmaceuticals Co. (NASDAQ: PPCO) announced today that on February 14, 2008, they received a notice from Actavis South Atlantic LLC advising of the filing by Actavis of an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release tablets CII....
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Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim Pharmaceuticals, Inc.'s Mirapex(R) Tablets (Pramipexole Dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg....
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The Indian government will consider whether it should grant permission for patented drugs to be manufactured and exported without the consent of the patent owners at a hearing scheduled for the last week of February....
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NEW YORK--(BUSINESS WIRE)--Feb 21, 2008 - Pfizer Inc said today that the Court of Appeal of The Hague in the Netherlands has ruled that the basic patent covering atorvastatin - the active ingredient in Lipitor - would be infringed by a competitor product from generics manufacturer Ranbaxy. ...
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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today the receipt of a positive opinion from the CHMP, the scientific committee of the European Medicines Agency ("EMEA"), for its human granulocyte colony stimulating factor ("G-CSF") product. ...
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Provisions of the patent reform bill currently pending before the Senate are likely to result in significant costs to the government, according to an estimate published Feb. 15 by the Congressional Budget Office. The provisions in question include targeted exceptions to the application of the Patent Act in specific instances.
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On February 13, 2008, the Hague District Court in the Netherlands, decided to revoke the Dutch part of Merck Sharp & Dohme's ("MSD") European Patent no. 1,175,904, due to lack of inventive step, which relates to Fosamax® Once Weekly (Alendronate 70mg Once Weekly)....
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Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by GlaxoSmithKline in connection with its Avodart(R) (dutasteride) soft gelatin capsules, 0.5mg....
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Sigma-Aldrich Co. has announced a licensing deal with NeuroSurvival Technologies Ltd. by which Sigma-Aldrich will be allowed to market and manufacture a marker that can detect apoptosis in vitro and in vivo. ...
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Drug firms and their allies have accused Bangkok of stealing intellectual property. The United States put Thailand on its "priority watch list", citing weaker respect for patents....
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Hospira, Inc. (NYSE: HSP), the world leader in generic injectable pharmaceuticals, today announced the launch of irinotecan hydrochloride injection in the United States. The medication is a generic version of Pfizer's Camptosar®, which posted 2007 U.S. sales of more than $545 million....
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of Hoffman la Roche’s Demadex®, torsemide tablets.
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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer's chemotherapy agent, Camptosar® (Irinotecan Hydrochloride) Injection, 20 mg/mL....
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Actavis recently received approval on four new products from the United States Food & Drug Administration....
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Pfizer Inc said today that it will seek to appeal a ruling of the Court of Appeal of The Hague in the Netherlands that Pfizer’s atorvastatin enantiomer patent is invalid. The patent (EP 409,281) had been challenged by generics manufacturer Ranbaxy and expires in July 2010. ...
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Teva announced today that a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Procter & Gamble's Actonel(R) (Risedronate Sodium) Tablets has been made...
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